When Insurers Practice Non-evidence Based Care

With the approval of new, innovative, yet expensive medications, doctors can expect their lives to become miserable as insurers do their best to limit costs. No where is this more apparent than with the introduction of our latest slew of novel oral anticoagulants.

What is remarkable (yet not the least bit surprising to those of us who have been in the business of medicine for a while) is how insurers dismiss the importance of discussions that are held by those of us who attempt to explain the pros and cons of the various new medications to our patients. We see these conversations completely invalidated as soon as the insurance industry renders their "coverage decision." Discussions are immediately invalidated, the pros and cons of each medication ignored. Meanwhile, these same insurers bear no reponsibility for potential safety issues that might arise when their made-up care process is implemented. And there is no accountability, no person ultimately responsible.

When a doctor tries to call and speak with someone about their policy, we meet hushed tones that promise to approve the prescribed medication if we just send a letter explaining our rationale. Yet despite this effort, they stick by their policy nonetheless.

What a waste.

So I'm sending a few questions to Aetna about their new "coverage decision" regarding the new oral anticoagulant, apixaban:

An Aetna 'Coverage Decision' (click to enlarge)

Dear Aetna Pharmacy Management:

1. When my patient has a GI bleed from Pradaxa, will you explain to them why you insisted I start this medication?
2. When my patient gets nauseated from Pradaxa, will you take the call at 3 am and write the new script for him or her?
3. When my patient accidentally overdoses on Xarelto thinking it was a twice a day drug like Pradaxa, will you explain to the plantiff's lawyer the safety of your non-evidenced based practice of switching anticoagulants on a monthly basis? 
4. Along the same line of reasoning, where I might find data pertaining to the safety of monthly switches of anticoagulants in the world's literature?
5. Is your effort to "manage" physician-prescribed medications in the patient's best interest or your stockholders'?
6. Where can I send the bill for the wasted time spent by my staff and me to jump through your self-imposed hoops?

Aetna, may your latest policy find disfavor with the FDA safety brigade.

With sarcastic love of all you do -

-Wes

The Iron Triangle and Evidence-based Medicine

From the Journal of Evaluation in Clinical Practice:

It is naïve to think that we can prevent vested interests from introducing bias. Politicians cannot tally their votes and in sport we rely on umpires, not player, to call the penalties. What are we thinking relying on industry provide evidence about health interventions that they have developed, believe in and stand to profit from? We need to recognize this inherent bias and take action against it.

It is beyond the scope of this paper to discuss practical solutions in great detail, however, we make the following suggestions:

1. The sensible campaign to formalize and enforce measure sensuring the registration and reporting of all clinical trials (see http:// www.alltrials.net/) should be supported – otherwise trials that do not give the answer industry wants will remain unpublished.
2. More investment in independent research is required. As we have described, it is a false economy to indirectly finance industry-funded research through the high costs of patented pharmaceuticals.
3. Independent bodies, informed democratically, need to set research priorities.
4. Individuals and institutions conducting independent studies should be rewarded by the methodological quality of their studies and not by whether they manage to get a positive result (a ‘negative’ study is as valuable as a ‘positive’ one from a scientific point of view).
5. Risk of bias assessment instruments susch as the Cochrane risk of bias tool should be amended to include funding source as an independent item.
6. Evidence-ranking schemes need to be modified to take the evidence about industry bias into account. There are already mechanisms within EBM evidence-ranking schemes to up- or downgrade evidence based on risk of bias. For example, the Grading of Recommendation Assessment, Development and Evaluation (GRADE) system allows for upgrading observational evidence demonstrating large effects, and downgrading randomized trials for failing to adequately conceal allocation (and various other factors). However, currently such schemes are agnostic to the origins of evidence and do not expressly recognize the high risk of bias when the producers of evidence have an invested interest in the results. It would be easy to introduce an evidence quality item based on whether a trial was conducted or funded by a body with a conflict of interest. If so, the evidence could be downgraded. Given the failure of current evidence-ranking schemes to detect and rule out industry-funding bias, this is a necessary step if EBM critical appraisal is to remain credible.

Read the whole thing.

-Wes

h/t: Ivan Oransky on Twitter